Rotator Cuff InjuriesICCNCT05095909
Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
A study testing Cryo-compression and Cryo-therapy in people with Rotator Cuff Injuries and Cryotherapy Effect, run by Allina Health System at 1 site in United States.
Trial summary
Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Injuries, Cryotherapy Effect
- What is being tested?
- Cryo-compression and Cryo-therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are candidates for arthroscopic rotator cuff repair
- Acute, traumatic tear of the rotator cuff in an active patient
- Chronic, symptomatic tear of the rotator cuff in an active patient having failed non - operative treatment
- Patient agreeable to participation in the study and able to complete informed consent process and all study requirements.
- ≥18 years of age
Who cannot join
- Pregnancy (per pre-operative physical)
- Presence of significant glenohumeral joint osteoarthritis
- Age over 70
- History of clinically diagnosed lymphedema
- Morbid obesity (BMI > 45)
- History of drug or alcohol addiction, prior opioid dependence, or current use of opioid medication (preoperative)
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- Investigators concern regarding subject's ability or willingness to follow protocol.
- History of significant vascular impairment in the affected region (e.g., from prior frostbite, diabetes, arteriosclerosis or ischemia).
- History of acute paroxysmal cold hemoglobinuria or cryoglobulinemia.
- History of Raynaud's disease or cold hypersensitivity (cold urticarial).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allina Health Orthopedics
Plymouth, Minnesota, 55441
Ned K Tervola, MA, LAT, ATC, 952-946-9777, ned.tervola@allina.com
L Pearce McCarty III, MD
About this study
Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.
Read the detailed description
The purpose of this study is to test the proposed increase efficacy of combining both cold and compression modalities through cryo-compression therapy in post-operative pain management in arthroscopic rotator cuff repair surgery versus a control group of standard ice wraps. As opioid use within the field of orthopedics continues to grow as an area of investigation, surgeons must look elsewhere for pain management tactics.
Objectives of this study include:
- Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair.
- Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair.
- Determine cost comparison of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps.
- Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via PROMIS.
Patients that are candidates for arthroscopic rotator cuff repair and complete informed consent process will be enrolled in study if no exclusion criteria are present. The study has determined an enrollment goal of 100 subjects (50 intermittent cryo-compression therapy, 50 standard cryo -therapy).
Following informed consent, patients enrolled in the study will be randomized in a 1:1 ratio using permuted blocks of sizes 2 and 4 to have post-operative cryotherapy using ice packs or with the intermittent cold compression therapy unit. Randomization assignments will be contained in sequentially numbered, opaque, sealed envelopes, which will be prepared by an individual not involved in patient consent or patient treatment. After the patient is consented, the next envelope in the sequence will be opened and the patient will be assigned to a group following the treatment listed in the envelope.
Prior to surgery, the subject will complete pre-operative data collection. The subject will be given a tracking diary in order to record immediate post-operative data through the first post-operative visit. Subjects will undergo arthroscopic rotator cuff repair by a single surgeon as a standard of care procedure.
Subjects randomized to the study group will have the compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively and those randomized to the control group a standard gel ice pack with wrap. Each will use the assigned version of cold therapy with a goal of 6 hours daily and will record overages using one half hour as a minimum unit.
After enrollment and surgery, subjects will follow a post-operative follow-up visit schedule including 2-days, first post-operative visit, 60 days, 3 months, 6 months, and 12 months.
- Conditions
- Rotator Cuff Injuries, Cryotherapy Effect
- Being tested
- Cryo-compression, Cryo-therapy
- Keywords
- Cryo-compression, Rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo-compressionDevice
Also called NICE Cold Therapy
Programmable intermittent compression with integrated cryo-therapy.
Cryo-therapyOther
Also called Gel ice pack
Subjects are fitted with gel ice packs and wraps.
| Study group | Role | What they receive |
|---|---|---|
| Cryo-compression | Experimental | Fitted with compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively Minimum 6 hours treatment per day post-operatively. Utilize cyro-compression unit with a "Medium" compression level (inflate to 35 mmHg for 2 minutes and then deflate to 5 mmHg for 30 seconds) and "Level 3" cooling (50F (10C)) for the first 24 hours. After that time, the compression and cooling levels will be up to the patients' discretion. Receives: Device: Cryo-compression |
| Cryo-therapy | Active comparator | Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs. Receives: Other: Cryo-therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain levels in the post-operative period using VAS Pain Scale.
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair. Pain levels will be documented by the VAS Pain Scale
Measured: up to 15 days
Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair by measuring circumference (inches) of upper arm using a flexible measuring tape.
Measured: up to 15 days
Secondary outcomes (2)
Cost analysis of post-operative cryotherapy modalities and other historical controls of pain post-operative pain control.
Determine cost differential of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps.
Measured: 10 days
Quality of life evaluation comparison of post-operative cryotherapy modalities using PROMIS Global-10 scale.
Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start5 Aug 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- L Pearce McCarty III, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095909
- Sponsor's protocol ID
- ICC2-2019
- Acronym
- ICC
- Status last verified
- Sep 2025
- First submitted
- 7 Oct 2021
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT05095909
- Acronym / sponsor ID
- ICC / ICC2-2019
- Conditions
- Rotator Cuff Injuries, Cryotherapy Effect
- Keywords
- Cryo-compression, Rotator cuff repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.
Detailed description
The purpose of this study is to test the proposed increase efficacy of combining both cold and compression modalities through cryo-compression therapy in post-operative pain management in arthroscopic rotator cuff repair surgery versus a control group of standard ice wraps. As opioid use within the field of orthopedics continues to grow as an area of investigation, surgeons must look elsewhere for pain management tactics.
Objectives of this study include:
- Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair.
- Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair.
- Determine cost comparison of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps.
- Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via PROMIS.
Patients that are candidates for arthroscopic rotator cuff repair and complete informed consent process will be enrolled in study if no exclusion criteria are present. The study has determined an enrollment goal of 100 subjects (50 intermittent cryo-compression therapy, 50 standard cryo -therapy).
Following informed consent, patients enrolled in the study will be randomized in a 1:1 ratio using permuted blocks of sizes 2 and 4 to have post-operative cryotherapy using ice packs or with the intermittent cold compression therapy unit. Randomization assignments will be contained in sequentially numbered, opaque, sealed envelopes, which will be prepared by an individual not involved in patient consent or patient treatment. After the patient is consented, the next envelope in the sequence will be opened and the patient will be assigned to a group following the treatment listed in the envelope.
Prior to surgery, the subject will complete pre-operative data collection. The subject will be given a tracking diary in order to record immediate post-operative data through the first post-operative visit. Subjects will undergo arthroscopic rotator cuff repair by a single surgeon as a standard of care procedure.
Subjects randomized to the study group will have the compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively and those randomized to the control group a standard gel ice pack with wrap. Each will use the assigned version of cold therapy with a goal of 6 hours daily and will record overages using one half hour as a minimum unit.
After enrollment and surgery, subjects will follow a post-operative follow-up visit schedule including 2-days, first post-operative visit, 60 days, 3 months, 6 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryo-compression | Experimental | Device: Cryo-compressionFitted with compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively Minimum 6 hours treatment per day post-operatively. Utilize cyro-compression unit with a "Medium" compression level (inflate to 35 mmHg for 2 minutes and then deflate to 5 mmHg for 30 seconds) and "Level 3" cooling (50F (10C)) for the first 24 hours. After that time, the compression and cooling levels will be up to the patients' discretion. |
| Cryo-therapy | Active comparator | Other: Cryo-therapyFitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are candidates for arthroscopic rotator cuff repair
- Patient agreeable to participation in the study and able to complete informed consent process and all study requirements.
- ≥18 years of age
Key exclusion criteria (10 listed)
- Pregnancy (per pre-operative physical)
- Presence of significant glenohumeral joint osteoarthritis
- Age over 70
- History of clinically diagnosed lymphedema
- Morbid obesity (BMI > 45)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryo-compressionAlso: NICE Cold TherapyProgrammable intermittent compression with integrated cryo-therapy. | Device | Cryo-compression |
| Cryo-therapyAlso: Gel ice packSubjects are fitted with gel ice packs and wraps. | Other | Cryo-therapy |
Primary outcome
Evaluation of pain levels in the post-operative period using VAS Pain Scale.
Time frame: up to 15 days
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair. Pain levels will be documented by the VAS Pain Scale
Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.
Time frame: up to 15 days
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair by measuring circumference (inches) of upper arm using a flexible measuring tape.
2 secondary outcomes
Cost analysis of post-operative cryotherapy modalities and other historical controls of pain post-operative pain control.
Time frame: 10 days
Quality of life evaluation comparison of post-operative cryotherapy modalities using PROMIS Global-10 scale.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
L Pearce McCarty III, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryo-compression and Cryo-therapy in people with Rotator Cuff Injuries and Cryotherapy Effect, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ned Tervola, MA, LAT, ATC (952-946-9777, ned.tervola@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain levels in the post-operative period using VAS Pain Scale. (time frame: up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.